Healthcare Professionals
Durepair Regeneration Matrix
DURA MATER REPAIR
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Healthcare Professionals
Durepair Regeneration Matrix
DURA MATER REPAIR
Durepair™ Regeneration Matrix is a non-synthetic dura substitute used to repair defects in the dura.
Cerebrospinal fluid (CSF) leaks during surgery often result in extra time in the operating room. A CSF leak after surgery may require re-operation – adding more time and cost to a patient’s care.1 In addition, products that are too delicate and difficult to handle can be time consuming and frustrating to work with.1 Durepair was manufactured to address these issues.
Durepair is a non-synthetic dura substitute for repair of the dura mater during neurosurgical procedures. It uses a patented technology to produce a strong yet flexible collagen matrix that can be applied as an onlay or suturable graft.2
Flexibility
Strength
Convenience
Durepair Dura Regeneration Matrix consists of both Type I and Type III collagen. Durepair is unique in that it uses Type III fetal bovine tissue that has gone through an extensive patented process to remove the cellular components. This leaves undamaged pure collagen that acts as a neutral tissue.6 The entanglement of strong collagen cables form a highly porous matrix — typically 10–20 micron pores. This matrix is a scaffold for the ingrowth of fibroblasts and blood vessels.2
Important Safety Information
In addition to the risks associated with any brain surgical procedure, such as bleeding, damage to surrounding brain tissue, seizures, stroke, or death, the following complications may also occur: infections, cerebrospinal fluid (CSF) leaks, adhesions, hematomas, rejection/foreign body reaction, inflammatory reactions, and calcification. At times the common complications can provide serious risks and should be treated promptly as such. It is important to review the product labeling for complete safety information, potential complications, contraindications, and a complete explanation of warnings and precautions.
Medtronic Durepair™ Dura Regeneration Matrix, LIT59427C; 2011.
Zerris et al. J of Biomed Mat Rsch 2007; 83B(2):580-588 (Canine Study).
Pollay M. and Lentz L. “Short-Term Evaluation of Medtronic Durepair®, DuraGen Plus™, and Duraform™ as Only Dural Grafts.” White Paper, LIT59502A; 2006.
Durepair™ Manual; Document Number 15614COM-1 Rev. T.
Durepair Dura Regeneration Matrix Product Evaluation Protocol No. 0203 Commercial Release Report, 16 March 2004.
Medtronic 510(k) #K041000.